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CSL Ltd. Interim / Quarterly Report 2025

Feb 10, 2025

17854_rns_2025-02-10_9b3c8a21-74de-4903-922c-a3d728c2fcda.pdf

Interim / Quarterly Report

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For immediate release

11 February 2025

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Results Presentation for the Half-year ended 31 December 2024

Melbourne, Australia – CSL (ASX:CSL; USOTC:CSLLY)

Please find attached the slides for the presentation on the half year results that will be given by the Chief Executive Officer and the Chief Financial Officer shortly.

The briefing will be webcast and can be accessed in the “Investor” section of CSL’s website (www.CSL.com).

Authorised for lodgement by:

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Fiona Mead Company Secretary

For further information, please contact:
Investors Media
Chris Cooper Brett Foley
Investor Relations Communications
CSL Limited CSL Limited
P: +61 455 022 740 P: +61 461 464 708
E: [email protected] E: [email protected]

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Driven by Our Promise

2025 Half Year Results 11 February 2025

Zahra K.

IMPORTANT NOTICE AND DISCLAIMER

This presentation contains summary information about CSL Limited (ACN 051 588 348) and its related bodies corporate (together, CSL) and CSL's activities as at the date of this presentation. It is information given in summary form only and does not purport to be complete. It should be read in conjunction with CSL's other periodic corporate reports and continuous disclosure announcements filed with the Australian Securities Exchange (ASX), available at www.asx.com.au. This presentation is for information purposes only and is not a prospectus or product disclosure statement, financial product or investment advice or a recommendation to acquire CSL shares or other securities.

No representation or warranty, express or implied, is made as to the fairness, accuracy, completeness or correctness of the information, opinions and conclusions contained in this presentation. To the maximum extent permitted by law, none of CSL or its directors, employees or agents, nor any other person, accepts liability for any loss arising from the use of this presentation or its contents or otherwise arising in connection with it, including, without limitation, any liability from fault or negligence on the part of CSL or its directors, employees, contractors or agents.

This presentation contains forward-looking statements in relation to CSL, including statements regarding CSL's intent, belief, goals, objectives, initiatives, commitments or current expectations with respect to CSL's business and operations, market conditions, results of operations and financial conditions, products in research, risk management practices, climate change and other environmental and energy transition scenarios. Forward-looking statements can generally be identified by the use of words such as "forecast", "estimate", "plan", "will", "anticipate", "may", "believe", "should", "expect", “project,” "intend", "outlook", "target", "assume" and "guidance" and other similar expressions.

The forward-looking statements are based on CSL's good faith assumptions as to the financial, market, risk, regulatory and other relevant environments that will exist and affect CSL's business and operations in the future. CSL does not give any assurance that the assumptions will prove to be correct. The forward-looking statements involve known and unknown risks, uncertainties and assumptions and other important factors, many of which are beyond the control of CSL, that could cause the actual results, performances or achievements of CSL to be materially different to future results, performances or achievements expressed or implied by the statements . Factors that could cause actual results to differ materially include: the success or otherwise of CSL’s research and development activities; factors affecting CSL’s ability to successfully market and sell new and existing products, including decisions by regulatory authorities regarding approval of CSL’s products and regarding label claims, competitive developments affecting CSL’s products, and trade buying patterns; factors affecting CSL’s ability to collect plasma, and difficulties or delays in manufacturing; legislation or regulations affecting the manufacturing, distribution, pricing, or reimbursement of CSL’s products, market access for CSL’s products, environmental protection matters, or tax; litigation or government investigations; fluctuations in interest and currency exchange rates; acquisitions or divestitures; and CSL’s ability to protects its patents and other intellectual property.

Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as at the date of the presentation. Except as required by applicable laws or regulations, CSL does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in assumptions on which any such statement is based.

TRADEMARKS

Except where otherwise noted, brand names designated by a or ® throughout this presentation are trademarks either owned by and/or licensed to CSL.

Driven by Our Promise

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CEO Overview

Financials

Outlook

CEO Overview

Paul McKenzie CEO & Managing Director

3

CEO Overview

Financials

Outlook

Solid 1H25 Performance[1]

CSL Behring

Strong growth driven by Ig

  • Ig +15%, ALBUMIN[®] +9%, IDELVION[®] +6%

Revenue +5% NPATA[2,3] +5%

  • Gross margin +170 bps at CC

  • Rika deployment well advanced

  • iNomi implemented and delivering planned benefits

  • HEMGENIX[®] uptake accelerating

NPAT[3] +7%

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1H25 Revenue Growth
Behring +10%
Seqirus (9%)
$8,483m
Vifor +6%
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1H25 Revenue Growth

FY25 NPATA[2,3] Guidance Reaffirmed +10-13%[1]

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  • ANDEMBRY[®] (Garadacimab) regulatory approvals progressing

CSL Seqirus

Weak seasonal markets to be partly offset by pandemic tenders

  • Low immunisation rates significantly impacting US influenza vaccine market; EU market stabilising

  • Commercial discipline in competitive environment

  • Pandemic tenders for avian influenza recognised through FY25

  • KOSTAIVE[®] launched by our partner in Japan

CSL Vifor

Growth driven by iron & nephrology

  • EU FERINJECT[® ] volume growth +6%

  • Geographic expansion

  • Successful launches of TAVNEOS[®] and FILSPARI[®]

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4

CEO Overview

Financials

Outlook

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Revenue $5,743m +10%[1]

Revenue $5,743m +10%1
5
Revenue ($m)
Change1
Ig
3,174
+15%
Albumin
672
+9%
Haemophilia
731
+11%
Specialty
921
(5%)
Performance
Major Brands
• Strong performance across all geographies
– PRIVIGEN®/ INTRAGAM®+15%, HIZENTRA®+16%
• Significant patient demand in all core indications
• HIZENTRA®
‒ Strong uptake of 50ml PFS
‒ Remains clear market leader in SCIG
• Strong growth in China driven by continued patient
demand and market share gains
• IDELVION®+6% remains the market leader
• HEMGENIX® uptake accelerating
• Plasma derived coagulants +6% led by VWF
• HAEGARDA® +1%, BERINERT® +6%
• KCENTRA®(20%)
‒ Impacted by loss of substantial contract
‒ Remains market leader in a growing market

Outlook

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Operational Highlights

CEO Overview Financials

  • Underlying fundamentals of plasma collection remain strong:

  • Plasma donations continuing to grow

  • Further reduction in CPL

  • Continued focus on driving centre efficiencies

Rika Plasma Donation System

  • Horizon 1 delivering tangible yield benefits

  • Horizon 2 yield initiatives progressing to plan

  • Gross margin continuing to improve

  • ANDEMBRY[® ] (Garadacimab):

    • Successfully rolled out to 220 centres

    • On track to complete US rollout by end-FY25:

      • Enhanced donor experience and reduced collection time
  • Approved in Australia and UK

  • CHMP positive recommendation in EU

  • Re-submitted BLA accepted by FDA in Dec-24

  • RiaSTAP[®] AFD Phase III first patient in

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  • iNomi implemented in RIKA centers:

  • Delivering anticipated increase in donor yield, on average ~10%

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6

CEO Overview

Financials

Outlook

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Revenue $1,661m (9%)[1]

Revenue $1,661m (9%)1
Therapy
Revenue ($m)
Change1
Egg Based
104
(16%)
Cell Culture
468
(12%)
Adjuvanted Egg
829
(17%)
In License / Other
143
+126%
Pandemic
Reservation Fees
89
+3%
Other Income
28
+93%
Performance
Major Brands

Revenue impacted by:

Decline in US vaccination rates

Shift in immunisation settings: medical vs pharmacy

Competitive pressures
• H5 avian flu preparedness revenue; majority recognised
beyond 1H25
• First revenue from KOSTAIVE® in Japan
• Successful Advanced Purchase Agreements
• Includes COVID milestone payments in Japan

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7

CEO Overview

Financials

Outlook

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Operational Highlights

Seasonal Influenza Products

Pandemic Influenza

Product Innovation

  • FLUCELVAX[®]

  • Positive CHMP opinion for 6- month+ age extension in EU

  • Launched in Switzerland

  • Selected by BARDA, HERA and the UK Government for delivery of H5 vaccines

  • New APA contract with Denmark awarded

    • Phase III immuno-clinical study for aTIVc

    • KOSTAIVE® launched by our partner in Japan

  • Listed on Australia's funded NIP

  • FLUAD[®]

  • Received preferential recommendation in Germany for 60+

  • Awarded central tender for key populations in Finland and Denmark

  • Launched in Taiwan and South Korea

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8

CEO Overview

Financials

Outlook

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Revenue $1,079m +6%[1]

Therapy Revenue ($m) Change1 Performance Performance Major Brands
EU FERINJECT® volume +6%
Iron 527 +3% US INJECTAFER® +3%
Launch of FERINJECT® in China and Canada on
track
a
Nephrology:
Dialysis
387 (3%)
MIRCERA®maintained market leadership in US
VELPHORO®strong demand
b c
d
TAVNEOS® strong growth in EU and increasing
Nephrology:
Non-Dialysis
127 +40% patient penetration
FILSPARI®successful launches in Germany,
Austria and Switzerland
  • a. Licensed from F. Hoffman-La Roche AG; b. Licensed from Pfizer Inc.; c. Licensed from Cara Therapeutics, Inc.; d. Ex-US rights licensed from

  • ChemoCentryx, Inc., a wholly owned subsidiary of Amgen, Inc.

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9

CEO Overview

Financials

Outlook

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Operational Highlights

Commercial Execution

  • FERINJECT[®]

  • Navigating competitive landscape and further expanded market

  • EU volume growth +6%

  • Significant unmet medical need remains

  • Nephrology

Product Innovation

  • VELTASSA[®]

    • Approved in Japan
  • CSL300 in ESKD

    • Global Phase III enrolment progressing to plan globally
  • Significant long-term growth opportunities in rare nephrology

  • Exceeding launch benchmarks for both TAVNEOS[®] and FILSPARI[®]

  • Successful VELPHORO[®] launch in China

  • Remain on track for 30+ country launches in FY25

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10

CEO Overview

Financials

Outlook

Financials

John Levy Interim CFO

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11

CEO Overview

Financials

Outlook

NPATA[2,3]

$2,017m
$2,074m
1H24 NPATA
1H25 NPATA @CC
FX $35m
$101m
$2,
9m
1H24
Rep
1H25
@ CC
Change
%1
NPATAto CSL equity
holders
$2,017m
$2,109m
+5%
$2,017m
$2,074m
1H24 NPATA
1H25 NPATA @CC
FX $35m
$101m
$2,
9m
Acquired IP amortisation
($132m)
($155m)
Other adjustments
($50m)
$39m*
Tax
$32m
$23m
NPATA
Attributable to NCI
$53m
$76m
NPAT
$1,920m
$2,092m
+9%
NPAT
Attributable to NCI
($19m)
($49m)
NPATto CSL equity
holders
$1,901m
$2,043m
+7%
  • Adjustment represents net gain on business disposal per ASX Announcement (30/8/2024). Refer to note 2 in the Financial Statements for more detail.

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12

CEO Overview

Financials

Outlook

CSL Group Financial Highlights

US$ Millions 1H24
Rep
1H25
Rep
1H25
at CC
1
Change
%
1
Total Revenue 8,053 8,483 8,470 5%
Gross Profit4 4,494 4,704 4,728 5%
GP %4 55.8% 55.5% 55.8%
Sales & Marketing4 707 754 754 7%
Operating Result4 3,787 3,950 3,974 5%
R&D4 669 646 644 (4%)
G&A4 323 426 410 27%
Finance (Net) 234 222 221 (6%)
NPATA3 2,017 2,074 2,109 5%
ETR % 19.2% 19.1% 19.0%
Cashflow From Ops 1,069 1,259 18%Y
NPATA EPS3($) 4.18 4.29 3%Y
NPAT EPS3($) 3.94 4.15 5%Y
DPS ($) 1.19 1.30 9%Y

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R&D

  • Lower first half due to cessation of CSL112

  • FY25 guidance ~10% of revenue

G&A

  • Includes timing of non-recurring project costs

  • FY25 guidance ~6% of revenue

Finance

  • Balance Sheet deleveraging to plan

Tax

  • In line with expectations

Cashflow from Operations

  • Increase in cash earnings from growth in sales and working capital initiatives

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Y. At reported currency

13

CEO Overview

Financials

Outlook

Segment Financial Highlights

CSL Behring

CSL Behring
US$ millions reported 1H24 1H25 Change
% at CC
1
Sales 5,093 5,611 10%
Other Revenue
Total Revenue
Gross Profit4
GP %4
Sales & Marketing
145
5,238
2,617
50.0%
396
132
5,743
2,937
51.7%1
434
(7%)
10%
14%
10%
Operating Result 2,221 2,503 14%
Operating Segment %4 42.4% 43.6%

Path to Gross Margin Recovery

CPL Reduction

New Products

ASP Mix Shift

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Ig Yield Improvements
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Scale & Efficiency Measures

Add Rika + INomi benefits

  • Optimise donor fees

  • • RIKA and I-Nomi • Centre efficiencies

  • HEMGENIX[®]

  • HIZENTRA[®] PFS

  • • ANDEMBRY[®]

Change to ANDEMBRY

  • HIZENTRA[®] v PRIVIGEN[®]

  • • Geographic mix

  • Horizon 1

  • Increased volume

  • • Variable v fixed costs • Manufacturing efficiencies

Excludes potential benefits of Horizon 2 initiatives

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Illustrative only

14

CEO Overview

Financials

Outlook

Segment Financial Highlights

CSL Seqirus

CSL Seqirus
US$ millions reported 1H24 1H25 Change
% at CC
1
Sales 1,705 1,544 (10%)
Other Revenue 99 117 16%
Total Revenue 1,804 1,661 (9%)
Gross Profit4 1,207 1,044 (14%)
GP %4 66.9% 63.2%1
Sales & Marketing 89 107 24%
Operating Result4 1,118 937 (17%)
Operating Segment %4 62.0% 56.4%

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CSL Vifor

CSL Vifor
US$ millions reported 1H24 1H25 Change
% at CC
1
Sales 1,006 1,058 5%
Other Revenue 5 21
Total Revenue 1,011 1,079 6%
Gross Profit4 670 723 7%
GP %4 66.3% 67.0%1
Sales & Marketing4 222 213 (5%)
Operating Result4 448 510 13%
Operating Segment %4 44.3% 47.3%

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15

CEO Overview

Financials

Outlook

Outlook Paul McKenzie CEO & Managing Director

16

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CEO Overview
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Financials Outlook

FY25 Outlook

CSL Behring

  • Underlying patient demand for Ig in core indications remains strong

  • Momentum in HEMGENIX[® ] uptake

  • Preparing for launch of ANDEMBRY[®] (Garadacimab)

  • Complete RIKA roll-out

  • Horizon 1 delivering tangible yield benefits

  • Horizon 2 yield initiatives progressing to plan

  • Improving gross margin

CSL Seqirus

  • Higher H5 avian influenza revenue in 2H

  • Preparation for FLUAD[®] launch in Germany

  • Tullamarine facility proceeding to validation

CSL Vifor

  • Maintain leadership position in iron

  • Continued momentum in nephrology

  • Geographic expansion

Guidance Reaffirmed

Revenue Growth

~ 5 - 7% @CC[1]

NPATA Growth

  • ~ 10 – 13% @CC[1,3] to

~$3.2 – $3.3b @CC[1.3]

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FY25 FX impact estimated to be a headwind of approximately $90m

17

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CSL Contacts

Chris Cooper Investor Relations  +61 455 022 740 [email protected] Bernard Ronchi Investor Relations  +61 431 060 964 [email protected]

Jimmy Baker Investor Relations  +61 450 909 211 [email protected]

Notes

(#) Constant currency removes the impact of exchange rate movements to facilitate comparability of operational performance for the Group. This is done in three parts: a) by converting the current year net profit of entities in the group that have reporting currencies other than US Dollars, at the rates that were applicable to the prior comparable period (translation currency effect); b) by restating material transactions booked by the group that are impacted by exchange rate movements at the rate that would have applied to the transaction if it had occurred in the prior comparable period (transaction currency effect); and c) by adjusting for current year foreign currency gains and losses. The sum of translation currency effect, transaction currency effect and foreign currency gains and losses is the amount by which reported net profit is adjusted to calculate the operational result.

General Disclaimer Non-IFRS

There are references to IFRS (International Financial Reporting Standards) and non-IFRS financial information in this document. Non-IFRS financial measures are financial measures other than those defined or specified under any relevant accounting standard and may not be directly comparable with other companies’ information. Non-IFRS financial measures are used to enhance the comparability of information between reporting periods, and enable further insight and a different perspective into the financial performance. Non-IFRS financial information should be considered in addition to, and is not intended to be a substitute for, IFRS financial information and measures. Non-IFRS financial measures are not subject to audit or review.

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Summary NPAT attributable to members of parent entity

of parent entity
Reportednetprofit after tax $2,007m
Currency effect $36m
Constant currency net profit after tax* $2,043m

Average exchange rates for major currencies for half year ended 31 December 2024/31 December 2023 include: USD/EUR (0.92/0.92), USD/AUD (1.50/1.53), USD/CHF (0.87/0.89), USD/CNY (7.16/7.24) and USD/GBP (0.77/0.80).

Summary NPATA2attributable to
members of the parent entity US$m
Reported net profit after tax 2,007
Amortisation of acquired intellectual property 125
Other adjustments (39)
Income tax credit on above adjustments (19)
NPATA2 attributable to members
of the parent entity
2,074
Currency effect attributable to members
of the parent entity
35
Constant Currency# NPATA2 attributable
to members of the parent entity
2,109

Summary Revenue

Summary Revenue
Reported revenue $8,483m
Currency effect ($13m)
Constant currency revenue* $8,470m
  • *Constant currency net profit after tax and constant currency sales

  • have not been audited or reviewed in accordance with Australian Auditing Standards.

Footnotes

  1. Percentages shown at constant currency to remove the impact of exchange rate movements, facilitating comparability of operational performance. See end note for further detail

  2. NPATA is defined as the statutory net profit after tax (NPAT) before impairment and amortisation of acquired intellectual property and non-recurring items resulting from business acquisitions and disposals (such as business acquisition and integration costs, the unwind of the inventory fair value uplift resulting from business acquisitions and net gain on business disposals).

  3. Attributable to the shareholders of CSL Limited

  4. Underlying results are adjusted to exclude impairment and amortisation of acquired intellectual property (IP) and non-recurring items resulting from business acquisitions and disposals (such as business acquisition and integration costs, the unwind of the inventory fair value uplift resulting from business acquisitions and net gain on business disposals).

NPATA to NPAT FY25 outlook – NPATA guidance unchanged

NPATA to NPAT adjustments,
attributable to:
Group CSL shareholders
(post tax)
CSL shareholders
(post tax)
FY24 FY25
Outlook
FY24 FY25
outlook
Amortisation of acquired
intellectual property
301 370 +/- 10% 203 260 +/- 10%
Other adjustments 84 (39) 62 (39)
Income tax credit on above
adjustments
(61) (60) +/- 10% - -
Total 324 271 +/- 10% 265 221 +/- 10%

19

Appendix

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20

Appendix A CSL Behring – Key Products

CSL Behring Therapy Group Sales $m Change1%
Privigen IVIG 2,024 15%
Hizentra SCIG 1,100 16%
Albumin Albumin 672 9%
Idelvion
Kcentra
Haemophilia
Specialty
413
293
6%
(20%)
Haegarda Specialty 247 1%
Berinert Specialty 127 6%
Haemocomplettan Specialty 119 4%
Humate Haemophilia 99 2%
Haemate Haemophilia 66 15%

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1H25 Revenue By Therapy Group $m

IVIG
SCIG
$2,074
$1,100
36%
19%
CSL Albumin $672 12%
Behring
Recombinants Coag $467 8%
Plasma Coag $216 4%
Peri-Operative Bleeding $451 8%
Other Specialty $470 8%
Other $293 5%

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21

Appendix B CSL Seqirus & CSL Vifor – Key Products

CSL Seqirus Therapy Group Sales $m Change1%
Fluad Adjuvanted 829 (17%)
Flucelvax
Afluria
Pandemic Res Fees
Cell culture
Egg-based
468
104
89
(12%)
(16%)
3%
CSL Vifor Therapy Group Sales $m Change1%
Ferinject / Injectafer Iron 397 5%
Mircera Dialysis 287 (8%)
Venofer
Velphoro
Iron
Dialysis
82
78
0%
67%
Veltassa Non Dialysis 76 15%
Tavneos Non Dialysis 49 117%
Maltofer Iron 45 (3%)

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1H25 Revenue By Therapy Group $m

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Cell Culture $468 28%
Adjuvanted $829 50%
Egg Based $104 6%
CSL
Seqirus In License $143 9%
Pandemic Res Fees $89 5%
Other Income $28 2%
Iron $527 49%
Dialysis $387 36%
CSL
Vifor Non Dialysis $127 12%
Other $38 3%
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22